The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Central Supply Room Wrap.
Device ID | K873175 |
510k Number | K873175 |
Device Name: | CENTRAL SUPPLY ROOM WRAP |
Classification | Wrap, Sterilization |
Applicant | ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
Contact | John Floren |
Correspondent | John Floren ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-12 |
Decision Date | 1987-09-09 |